Regulatory Affairs Manager
Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm Research & Manufacturing is a pharmaceutical research, development and production company with GMP facilities certified by the major regulatory authorities. It is the center of expertize for medicinal chemistry for the Group. The company is a world leader in polylactic-co-glycolic acid (PLGA)-based injectables.
Manage regulatory aspects of future submissions, maintenance and post marketing of drug products including extension of indications in Switzerland, USA and Canada.
- Maintenance of DMF drug products in USA and Canada
- Define, develop and lead regulatory strategies for assigned territories
- Coordinate with partners’ regional regulatory teams for global strategy
- Act as liaison with regulatory authorities
- Prepare and Review regulatory submissions
- Maintain policy & regulatory intelligence
- Provide regulatory strategies for manufacturing plans/process projects as RA representative in cross-functional teams
- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent
- 10 years’ experience in Pharmaceutical regulatory affairs in Switzerland, USA and Canada
- Maintenance, Renewal, Extension of indication
- Pharmacovigilance, DMF; meeting with Health agencies
- Fluent in French, English and German
- Strategic experience for products and experience of Health Authorities meetings
- Fluency in French and English (oral and written), knowledge of Spanish and German is desiderable
- Strong attention to details and organizational skills required
- Good written and oral communication, technical writing and editing skills
- Able to work independently with minimal supervision.